Teva Pharmaceuticals USA Recall: Metformin Hydrochloride Extended - Release Tablets, USP,
Teva Pharmaceuticals USA Recall: Metformin Hydrochloride Extended - Release Tablets, USP, is one of 9,000 recalls in the RecallGuard dataset. Key details — Recalling firm: Teva Pharmaceuticals USA; Product: Metformin Hydrochloride Extended - Release Tablets, USP, 500 mg, a) 100 (NDC 62037-571-01) and b) 1,000 (NDC 6203
| Recalling firm | Teva Pharmaceuticals USA |
|---|---|
| Product | Metformin Hydrochloride Extended - Release Tablets, USP, 500 mg, a) 100 (NDC 62037-571-01) and b) 1,000 (NDC 62037-571-10) count bottles, Rx Only, Manufactured by: Watson Pharma Private Limited, Verna, Salcette Goa, Distributed by: Actavis Pharma, Inc., Parsippany, NJ |
| Reason for recall | CGMP Deviations: FDA analysis detected N-Nitrosodimethylamine (NDMA) impurity above the acceptable intake level |
| Classification | Class II (moderate — may cause temporary or reversible health consequences) |
| Status | Terminated |
| Distribution | Product was distributed throughout the United States, including Puerto Rico. |
| Recall initiated | 20200602 |
| Recall number | D-1331-2020 |
| Category | drug |
| State | NJ |
| Country | United States |
$29/mo
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